Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Merck
McKinsey
Dow
Boehringer Ingelheim

Last Updated: May 26, 2022

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-two patents protecting this drug.

This drug has four hundred and one patent family members in forty-six 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 for a Free 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
University of WashingtonPhase 3
Dasman Diabetes InstitutePhase 4
Peking Union Medical College HospitalPhase 4

See all BYDUREON PEN clinical trials

US Patents and Regulatory Information for BYDUREON PEN

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

Patents protecting BYDUREON PEN

C-aryl glucoside SGLT2 inhibitors and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Residual solvent extraction method and microparticles produced thereby
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Residual solvent extraction method and microparticles produced thereby
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Administering apparatus with functional drive element
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating diabetes and reducing body weight
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Device for administering fluid from a multi-chamber ampoule in incremental steps
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Mixing device for a two-chamber ampoule
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ampoule comprising an ampoule holder
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Administering apparatus with functional drive element
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Administering device with holding mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for treating diabetes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ampoule comprising an ampoule holder
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for administering a fluid active substance from a multi-chamber ampoule
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating diabetes and reducing body weight
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting BYDUREON PEN

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITES
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 See Plans and Pricing See Plans and Pricing
>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
Germany 112010005187 Künstliche Motorgeräusch-Steuereinheit, Annäherungsfahrzeugschallsystemund elektrisches Fahrzeug, das sie aufweist See Plans and Pricing
Norway 20065217 See Plans and Pricing
China 1896088 C-aryl glucoside sglt2 inhibitors See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BYDUREON PEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140145 CA 2007 00033 Denmark See Plans and Pricing PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120
1506211 92496 Luxembourg See Plans and Pricing PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
0996459 0790031-9 Sweden See Plans and Pricing PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Dow
Johnson and Johnson
Moodys
Boehringer Ingelheim

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.