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Serving 500+ biopharmaceutical companies globally:

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Generated: June 24, 2017

DrugPatentWatch Database Preview

BYDUREON PEN Drug Profile

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Which patents cover Bydureon Pen, and what generic Bydureon Pen alternatives are available?

Bydureon Pen 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 ninety-six patent family members in thirty-two countries.

The generic ingredient in BYDUREON PEN 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 PEN

Patents:20
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list11
Clinical Trials: see list144
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BYDUREON PEN at DailyMed

Pharmacology for Tradename: BYDUREON PEN

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, 2014RXYesYes7,223,440► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes6,858,576► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes7,563,871► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes6,479,065► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes7,456,254► SubscribeY ► Subscribe
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Expired Patents for Tradename: BYDUREON PEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 20145,424,286► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 20146,858,576► Subscribe
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Non-Orange Book Patents for Tradename: BYDUREON PEN

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
8,617,613Polymer-based sustained release device► Subscribe
8,263,550Exendin agonist compounds► Subscribe
8,026,210Exendins and exendin agonist analogs to regulate gastrointestinal motility► Subscribe
8,288,338Exendin and exendin agonists for eating disorders► Subscribe
7,297,761Pharmaceutical compositions containing exendins► 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 PEN

Country Document Number Estimated Expiration
European Patent Office1971362► Subscribe
Austria516834► Subscribe
Germany69739172► Subscribe
Australia5546301► Subscribe
Canada2406536► 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 PEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012000028Germany► SubscribePRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
989Luxembourg► Subscribe91989, EXPIRES: 20260617
8 5006-2012Slovakia► SubscribePRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
1734971/01Switzerland► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
4Finland► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cipla
Chubb
McKesson
Moodys
Harvard Business School
Colorcon
Covington
Medtronic
Novartis
Federal Trade Commission

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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