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BYETTA Drug Profile

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Which patents cover Byetta, and what substitute generic drugs 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 forty-two patent family members in twenty-one 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.

Summary for Tradename: BYETTA

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list12
Clinical Trials: see list99
Patent Applications: see list6
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BYETTA at DailyMed

Pharmacology for Tradename: BYETTA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes7,521,423► SubscribeY ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes6,902,744► SubscribeY ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes5,424,286► Subscribe ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes6,858,576► Subscribe ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes7,741,269► Subscribe ► 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, 20055,424,286► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 20056,858,576► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 20055,424,286► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 20056,858,576► Subscribe
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Paragraph IV activity 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
8,263,550Exendin agonist compounds► Subscribe
6,989,366Exendins, exendin agonists, and methods for their use► Subscribe
7,858,740Exendin agonist compounds► 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: BYETTA

Country Document Number Estimated Expiration
Australia4063697► Subscribe
Cyprus1107829► Subscribe
Norway2010012► Subscribe
Australia757748► Subscribe
China100356978► 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
0526Netherlands► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
2007 00034Denmark► Subscribe
1734971/01Switzerland► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
343Luxembourg► Subscribe91343, EXPIRES: 20211120
4Finland► Subscribe
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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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