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Serving leading biopharmaceutical companies globally:

Deloitte
Express Scripts
Johnson and Johnson
Covington
Queensland Health
AstraZeneca
Chubb
Cerilliant
Moodys
McKinsey

Generated: November 24, 2017

DrugPatentWatch Database Preview

BYETTA Drug Profile

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What is the patent landscape for Byetta, and what generic Byetta alternatives are available?

Byetta is a drug marketed by Astrazeneca Ab and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-eight patent family members in twenty-one countries and thirteen supplementary protection certificates in eight countries.

The generic ingredient in BYETTA 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.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► 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
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: BYETTA

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;SUBCUTANEOUS021773-001Apr 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
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005► 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
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for BYETTA

Drugname Dosage Strength RLD Submissiondate
exenatideInjection250 mg/mL, 1.2 mL and 2.4 mL prefilled syringeByetta6/11/2014

Non-Orange Book Patents for Tradename: BYETTA

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
7,407,932Methods for glucagon suppression using modified exendins► Subscribe
8,288,338Exendin and exendin agonists for eating disorders► Subscribe
8,263,550Exendin agonist compounds► Subscribe
6,989,366Exendins, exendin agonists, and methods for their use► Subscribe
7,157,555Exendin agonist compounds► Subscribe
7,220,721Exendin agonist peptides► Subscribe
7,696,161Exendin agonist compounds► Subscribe
7,419,952Use of exendins and agonists thereof to treat diabetes► Subscribe
7,700,549Exendin agonist analogs to treat diabetes► Subscribe
7,906,146Lyophilized formulations of exendins and exendin agonist analogs► 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: BYETTA

Country Document Number Estimated Expiration
Luxembourg91342► Subscribe
Russian Federation2247575► Subscribe
China101181236► Subscribe
Canada2262647► Subscribe
Canada2299425► Subscribe
Germany122007000044► Subscribe
Norway328077► Subscribe
Denmark0996459► Subscribe
Netherlands300281► Subscribe
Australia2004202293► 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: BYETTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012000028Germany► SubscribePRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
0526Netherlands► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
4Finland► Subscribe
30/2007Austria► SubscribePRODUCT NAME: EXENATIDE
0996459/01Switzerland► SubscribeFORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
2007 00033Denmark► Subscribe
31/2007Austria► SubscribePRODUCT NAME: EXENATIDE
1734971/01Switzerland► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
343Luxembourg► Subscribe91343, EXPIRES: 20211120
342Luxembourg► Subscribe91342, EXPIRES: 20211120
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Boehringer Ingelheim
Cerilliant
US Army
Harvard Business School
Express Scripts
Fuji
Medtronic
Moodys
Teva

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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