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Serving leading biopharmaceutical companies globally:

Deloitte
Fish and Richardson
McKinsey
Covington
Healthtrust
Daiichi Sankyo
Medtronic
Moodys
US Department of Justice
McKesson

Generated: October 20, 2017

DrugPatentWatch Database Preview

EXENATIDE SYNTHETIC - Generic Drug Details

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What are the generic drug sources for exenatide synthetic and what is the scope of exenatide synthetic freedom to operate?

Exenatide synthetic
is the generic ingredient in three branded drugs marketed by Astrazeneca Ab and is included in two NDAs. There are twenty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Exenatide synthetic has three hundred and thirty-five patent family members in thirty-two countries and eighteen supplementary protection certificates in eleven countries.

There are seven drug master file entries for exenatide synthetic. Three suppliers are listed for this compound.

Summary for Generic Name: EXENATIDE SYNTHETIC

US Patents:23
Tradenames:3
Applicants:1
NDAs:2
Drug Master File Entries: see list7
Suppliers / Packagers: see list3
Bulk Api Vendors: see list12
Clinical Trials: see list885
Patent Applications: see list6
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:EXENATIDE SYNTHETIC at DailyMed

Pharmacology for Ingredient: EXENATIDE SYNTHETIC

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
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► Subscribe► SubscribeY ► 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
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: exenatide synthetic

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005► Subscribe► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005► Subscribe► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005► Subscribe► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012► Subscribe► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005► Subscribe► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005► Subscribe► Subscribe
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
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005► 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 Generic Ingredient: exenatide synthetic

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
7,799,345Preparation of injectable suspensions having improved injectability► Subscribe
7,220,721Exendin agonist peptides► Subscribe
8,293,871Poly(lactide-co-glycolide) based sustained release microcapsules comprising a polypeptide and a sugar► Subscribe
7,906,146Lyophilized formulations of exendins and exendin agonist analogs► Subscribe
7,399,489Exendin analog formulations► Subscribe
8,288,338Exendin and exendin agonists for eating disorders► Subscribe
6,989,366Exendins, exendin agonists, and methods for their use► Subscribe
7,696,161Exendin agonist compounds► Subscribe
8,877,252Polymer-based sustained release device► Subscribe
6,296,842 Process for the preparation of polymer-based sustained release compositions► 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 Ingredient: exenatide synthetic

Country Document Number Estimated Expiration
Canada2619426► Subscribe
MexicoPA06011924► Subscribe
China101181236► Subscribe
Cyprus1107441► Subscribe
Japan2003522721► Subscribe
Denmark2016950► Subscribe
Cyprus1107883► Subscribe
World Intellectual Property Organization (WIPO)2008122360► Subscribe
Germany122007000001► Subscribe
European Patent Office1066314► 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: EXENATIDE SYNTHETIC

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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Serving leading biopharmaceutical companies globally:

Queensland Health
Argus Health
Farmers Insurance
Boehringer Ingelheim
Cipla
Accenture
Johnson and Johnson
US Army
Dow
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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