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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Mallinckrodt
AstraZeneca
US Army
Farmers Insurance
Deloitte
Citi
Accenture
UBS
McKesson

Generated: October 23, 2017

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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 three hundred and twenty patent family members in thirty-two countries and eighteen supplementary protection certificates in eleven 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

US Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list11
Clinical Trials: see list27
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, 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
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► 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
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► Subscribe► Subscribe ► 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012► Subscribe► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012► Subscribe► 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
7,858,740Exendin agonist compounds► Subscribe
8,877,252Polymer-based sustained release device► Subscribe
7,521,423Exendin pharmaceutical compositions► Subscribe
7,399,489Exendin analog formulations► Subscribe
6,296,842 Process for the preparation of polymer-based sustained release compositions► Subscribe
7,906,146Lyophilized formulations of exendins and exendin agonist analogs► Subscribe
8,389,472Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease► Subscribe
8,293,871Poly(lactide-co-glycolide) based sustained release microcapsules comprising a polypeptide and a sugar► Subscribe
7,115,569Exendins, exendin agonists, and methods for their use► Subscribe
7,153,825Methods 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

Country Document Number Estimated Expiration
Austria493998► Subscribe
World Intellectual Property Organization (WIPO)0041548► Subscribe
Hong Kong1054319► Subscribe
Denmark1283699► Subscribe
Israel160378► Subscribe
Australia757748► Subscribe
Norway328077► Subscribe
European Patent Office0996459► Subscribe
Russian Federation2421237► Subscribe
Brazil9814189► 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
2012000028Germany► SubscribePRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
0996459/01Switzerland► SubscribeFORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
989Luxembourg► Subscribe91989, EXPIRES: 20260617
00526Netherlands► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
4Finland► Subscribe
31/2007Austria► SubscribePRODUCT NAME: EXENATIDE
2007 00033Denmark► Subscribe
1734971/01Switzerland► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
90031-9Sweden► SubscribePRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
0526Netherlands► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Chubb
Medtronic
QuintilesIMS
Citi
Farmers Insurance
Cerilliant
Deloitte
Daiichi Sankyo
Accenture

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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