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

Last Updated: March 28, 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 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

Indicators of Generic Entry

< Available with Subscription >

  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

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

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

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

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

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

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

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

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

Mixing device for a two-chamber ampoule
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

Administering device with holding mechanism
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method for treating diabetes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

FDA Regulatory Exclusivity protecting BYDUREON PEN

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

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
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
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
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
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
New Zealand 536605 C-aryl glucoside inhibitors of sodium dependent glucose transporters found in the intestine and kidney (SGLT2) ⤷  Try a Trial
Hong Kong 1205689 乳酸-羥基乙酸 共聚物為基礎、含有多肽和糖的持續釋放微膠囊 (POLY(LACTIDE-CO-GLYCOLIDE)-BASED SUSTAINED RELEASE MICROCAPSULES COMPRISING A POLYPEPTIDE AND A SUGAR. (-)) ⤷  Try a Trial
European Patent Office 2139494 PRÉPARATIONS PHARMACEUTIQUES CONTENANT DE L'HYDRATE DE PROPYLÈNEGLYCOL DE DAPAGLIFLOZINE (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE) ⤷  Try a Trial
Australia 2011200663 Exendin for treating diabetes and reducing body weight ⤷  Try a Trial
Denmark 1246638 ⤷  Try a Trial
Cyprus 1112348 ⤷  Try a Trial
Taiwan 200904405 Pharmaceutical formulations containing an SGLT2 inhibitor ⤷  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
1734971 122012000028 Germany ⤷  Try a Trial PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
0996459 0790031-9 Sweden ⤷  Try a Trial PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
1506211 C 2013 012 Romania ⤷  Try a Trial 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 [...]
1140145 91343 Luxembourg ⤷  Try a Trial 91343, EXPIRES: 20211120
1506211 122014000071 Germany ⤷  Try a Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
2139494 CA 2020 00035 Denmark ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719
0996459 CA 2007 00034 Denmark ⤷  Try a Trial
>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.