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Serving leading biopharmaceutical companies globally:

Express Scripts
Covington
Colorcon
Boehringer Ingelheim
Chinese Patent Office
Argus Health
Fuji
Citi
US Department of Justice
Accenture

Generated: October 20, 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 three hundred and thirty-five patent family members in thirty-two countries and eighteen supplementary protection certificates in eleven 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

US Patents:20
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list11
Clinical Trials: see list147
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, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► 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, 2014► Subscribe► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014► Subscribe► 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
7,906,146Lyophilized formulations of exendins and exendin agonist analogs► Subscribe
7,521,423Exendin pharmaceutical compositions► Subscribe
7,297,761Pharmaceutical compositions containing exendins► Subscribe
8,758,292Administering apparatus with functional drive element► Subscribe
7,220,721Exendin agonist peptides► Subscribe
7,700,549Exendin agonist analogs to treat diabetes► Subscribe
6,296,842 Process for the preparation of polymer-based sustained release compositions► Subscribe
8,187,672Residual solvent extraction method and microparticles produced thereby► Subscribe
8,288,338Exendin and exendin agonists for eating disorders► Subscribe
7,407,932Methods for glucagon suppression using modified 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 Office1734935► Subscribe
China101181236► Subscribe
South Korea20100129799► Subscribe
Cyprus1107441► Subscribe
Austria381939► Subscribe
Japan2003522721► Subscribe
Denmark2016950► Subscribe
Cyprus1107883► Subscribe
Germany122007000001► Subscribe
Japan2010523181► 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.

Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: BYDUREON PEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4Finland► Subscribe
0120006 00104Estonia► SubscribePRODUCT NAME: EKSENATIID;REG NO/DATE: K(2011)4479 LOPLIK 23.06.2011
2012000028Germany► SubscribePRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
2012006Lithuania► SubscribePRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
2007 00034Denmark► Subscribe
90031-9Sweden► SubscribePRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
2012 00015Denmark► Subscribe
30/2007Austria► SubscribePRODUCT NAME: EXENATIDE
0526Netherlands► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
31/2007Austria► SubscribePRODUCT NAME: EXENATIDE
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Accenture
AstraZeneca
Queensland Health
Cantor Fitzgerald
Harvard Business School
Cerilliant
Citi
US Department of Justice
Teva
Chinese Patent Office

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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