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Serving leading biopharmaceutical companies globally:

Moodys
US Department of Justice
Fuji
Medtronic
Merck
Harvard Business School
Chinese Patent Office
Novartis
Cantor Fitzgerald
Argus Health

Generated: December 12, 2017

DrugPatentWatch Database Preview

BYDUREON PEN Drug Profile

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

Bydureon Pen is a drug marketed by Astrazeneca Ab and is included in one NDA. There are thirty-seven patents protecting this drug.

This drug has five hundred and sixty-one patent family members in forty-six countries and forty-five supplementary protection certificates in thirteen 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► 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 AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014► Subscribe► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR 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
7,700,549Exendin agonist analogs to treat diabetes► Subscribe
7,521,423Exendin pharmaceutical compositions► Subscribe
7,875,310Residual solvent extraction method and microparticles produced thereby► Subscribe
8,026,210Exendins and exendin agonist analogs to regulate gastrointestinal motility► Subscribe
8,293,871Poly(lactide-co-glycolide) based sustained release microcapsules comprising a polypeptide and a sugar► Subscribe
7,297,761Pharmaceutical compositions containing exendins► Subscribe
7,157,555Exendin agonist compounds► Subscribe
8,389,472Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease► Subscribe
6,296,842 Process for the preparation of polymer-based sustained release compositions► Subscribe
8,288,338Exendin and exendin agonists for eating disorders► 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
Norway2010010► Subscribe
Hong Kong1176004► Subscribe
Slovenia2409707► Subscribe
Serbia53814► Subscribe
World Intellectual Property Organization (WIPO)2007024700► Subscribe
Germany112010005187► Subscribe
Spain2526463► Subscribe
Austria304864► Subscribe
Canada2653344► Subscribe
Germany60128798► 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
13/013Ireland► SubscribePRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
2007 00034Denmark► Subscribe
0120006 00104Estonia► SubscribePRODUCT NAME: EKSENATIID;REG NO/DATE: K(2011)4479 LOPLIK 23.06.2011
2013008Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
30/2007Austria► SubscribePRODUCT NAME: EXENATIDE
343Luxembourg► Subscribe91343, EXPIRES: 20211120
6 5005-2013Slovakia► SubscribePRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112
2007 00033Denmark► Subscribe
2013000033Germany► SubscribePRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
2012000028Germany► SubscribePRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
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Serving leading biopharmaceutical companies globally:

Fuji
QuintilesIMS
Harvard Business School
McKinsey
Cipla
Johnson and Johnson
Fish and Richardson
US Department of Justice
Mallinckrodt
Express Scripts

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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