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Last Updated: March 18, 2024

BYDUREON PEN Drug Patent 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 twenty patents protecting this drug.

This drug has three hundred and ninety-seven patent family members in forty-eight countries.

The generic ingredient in BYDUREON PEN is exenatide synthetic. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.

DrugPatentWatch® Generic Entry Outlook for Bydureon Pen

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Drug patent expirations by year for BYDUREON PEN
Drug Prices for BYDUREON PEN

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Recent Clinical Trials for BYDUREON PEN

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SponsorPhase
The University of Texas Health Science Center, HoustonPhase 2
University of WashingtonPhase 3
Dasman Diabetes InstitutePhase 4

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US Patents and Regulatory Information for BYDUREON PEN

BYDUREON PEN is protected by twenty US patents and two FDA Regulatory Exclusivities.

Patents protecting BYDUREON PEN

C-aryl glucoside SGLT2 inhibitors and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Polymer-based sustained release device
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Patent Expiration: ⤷  Try a Trial

Polymer-based sustained release device
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Patent Expiration: ⤷  Try a Trial

Polymer-based sustained release device
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Patent Expiration: ⤷  Try a Trial

Administering apparatus with functional drive element
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Patent Expiration: ⤷  Try a Trial

Methods for treating diabetes and reducing body weight
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Patent Expiration: ⤷  Try a Trial

Pharmaceutical formulations containing an SGLT2 inhibitor
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Patent Expiration: ⤷  Try a Trial

Polymer-based sustained release device
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Patent Expiration: ⤷  Try a Trial

Device for administering fluid from a multi-chamber ampoule in incremental steps
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Patent Expiration: ⤷  Try a Trial

Polymer-based sustained release device
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Patent Expiration: ⤷  Try a Trial

Crystal structures of SGLT2 inhibitors and processes for preparing same
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Patent Expiration: ⤷  Try a Trial

Mixing device for a two-chamber ampoule
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Ampoule comprising an ampoule holder
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Administering apparatus with functional drive element
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Administering device with holding mechanism
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Method for treating diabetes
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Patent Expiration: ⤷  Try a Trial

Ampoule comprising an ampoule holder
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Patent Expiration: ⤷  Try a Trial

Polymer-based sustained release device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method for administering a fluid active substance from a multi-chamber ampoule
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Patent Expiration: ⤷  Try a Trial

Methods for treating diabetes and reducing body weight
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FDA Regulatory Exclusivity protecting BYDUREON PEN

NEW PATIENT POPULATION
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PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BYDUREON PEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BYDUREON PEN

See the table below for patents covering BYDUREON PEN around the world.

Country Patent Number Title Estimated Expiration
Taiwan 200811127 Crystal structures of SGLT2 inhibitors and processes for preparing same ⤷  Try a Trial
European Patent Office 1754469 Suspensions injectables ayant des charactéristiques d'injectabilité ameliorées (Injectable suspensions having improved injectability properties) ⤷  Try a Trial
European Patent Office 1569673 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BYDUREON PEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 132014902277722 Italy ⤷  Try a Trial PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1506211 CA 2014 00037 Denmark ⤷  Try a Trial PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1734971 C 2012 010 Romania ⤷  Try a Trial PRODUCT NAME: EXENATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/11/696/001, EU/1/11/696/002; DATE OF NATIONAL AUTHORISATION: 20110623; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/696/001, EMEA EU/1/11/696/002; DATE OF FIRST AUTHORISATION IN EEA: 20110623
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.