You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 20, 2024

BYDUREON PEN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 four hundred and eight 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

Indicators of Generic Entry

< Available with Subscription >

  Sign Up

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

See drug prices for BYDUREON PEN

Recent Clinical Trials for BYDUREON PEN

Identify potential brand extensions & 505(b)(2) entrants

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

See all BYDUREON PEN clinical trials

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Administering apparatus with functional drive element
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for treating diabetes and reducing body weight
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Device for administering fluid from a multi-chamber ampoule in incremental steps
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Mixing device for a two-chamber ampoule
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Ampoule comprising an ampoule holder
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Administering apparatus with functional drive element
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Administering device with holding mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method for treating diabetes
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Ampoule comprising an ampoule holder
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method for administering a fluid active substance from a multi-chamber ampoule
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for treating diabetes and reducing body weight
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting BYDUREON PEN

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Sign Up ⤷  Sign Up
>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
Hong Kong 1050477 ⤷  Sign Up
Austria 275967 ⤷  Sign Up
Russian Federation 2643764 СПОСОБЫ ПОЛУЧЕНИЯ И ИСПОЛЬЗОВАНИЯ ИНГИБИТОРА SGLT2 (METHODS FOR SGLT2 INHIBITOR OBTAINING AND APPLICATION) ⤷  Sign Up
Australia 770712 ⤷  Sign Up
China 101687080 Device for administering a fluid active substance from a multi-chamber ampoule ⤷  Sign Up
Hong Kong 1066465 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BYDUREON PEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 2013/013 Ireland ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211 300677 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1506211 C 2013 012 Romania ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZIN SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA (2S, 3R, 4R, 5S, 6R)-2-[4-CLOR-3-(4-ETOXIBENZIL)FENIL]-6-(HIDROXIMETIL)TETRAHIDRO-2H-PIRAN-3,4,5-TRIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/795/001, RO EU/1/12/795/002, RO EU/1/12/795/003, RO EU/1/12/795/004, RO EU/1/12/795/005, RO EU/1/12/795/006, RO EU/1/12/795/007, RO EU/1/12/795/008, RO EU/1/12/795/009, RO EU/1/12/795/001/010; DATE OF NATIONAL AUTHORISATION: 20121112; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/795/001, EMEA EU/1/12/795/002, EMEA EU/1/12/795/003, EMEA EU/1/12/795/004, EMEA EU/1/12/795/005, EMEA EU/1/12/795/006, EMEA EU/1/12/795/007, EMEA EU/1/12/795/008 [...]
1506211 CA 2013 00019 Denmark ⤷  Sign Up
2139494 2090034-6 Sweden ⤷  Sign Up PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE; REG. NO/DATE: EU/1/16/1108 20160719
2139494 2020C/533 Belgium ⤷  Sign Up PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.