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Exenatide synthetic - Generic Drug Details

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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.

This ingredient has two hundred and ninety-one patent family members in thirty-two countries.

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

Summary for Generic Name: exenatide synthetic

Tradenames:3
Patents:23
Applicants:1
NDAs:2
Drug Master File Entries: see list7
Suppliers / Packagers: see list3
Bulk Api Vendors: see list12
Clinical Trials: see list424
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes5,424,286► subscribe ► subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes6,956,026► subscribe ► subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes8,329,648► 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
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 20145,424,286► subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 20055,424,286► subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 20146,858,576► 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
7,115,569Exendins, exendin agonists, and methods for their use► subscribe
7,700,549Exendin agonist analogs to treat diabetes► subscribe
7,407,932Methods 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 Ingredient: exenatide synthetic

Country Document Number Estimated Expiration
Japan4426727► subscribe
Germany60239469► subscribe
European Patent Office2409707► 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
90031-9Sweden► subscribePRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
1734971/01Switzerland► subscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
0120006 00104Estonia► subscribePRODUCT NAME: EKSENATIID;REG NO/DATE: K(2011)4479 LOPLIK 23.06.2011
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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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